Kornimate/medical-research-clean huggingface dataset:
a study of ly3202626 in healthy participants and participants with alzheimer's disease

Conditions: Healthy Volunteers; Alzheimer Disease

Summary: this study involves single and multiple doses of ly3202626 and will evaluate the effects of ly3202626 on the body. there will be 4 parts to this study. in parts a and b, single increasing doses of ly3202626 will be given in capsule form. part a will also include itraconazole given orally as a solution. part a will last approximately 8-12 weeks. part b will last approximately 5-6 weeks. in parts c and d, participants will be dosed multiple days with the study drug. part c will last approximately 11-14 weeks. part d will last approximately 11-14 weeks and participants must have alzheimer's disease. participants may only enroll in one part.


Eligibility criteria:
inclusion criteria: * for parts a, b, and c, are overtly healthy males or females (nonchildbearing potential), as determined by medical history and physical examination * have a body mass index (bmi) of 18 to 32 kilograms per square meter (kg/m\^2) * for part d, present with mild cognitive impairment (mci) due to alzheimer's disease (ad) or mild to moderate ad * have venous access sufficient to allow for blood sampling * are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and research unit policies exclusion criteria: * taking over-the-counter or prescription medication with the exception of vitamins or minerals * smoke more than 10 cigarettes per day * are unwilling or unable to refrain from eating any food or drinking any beverage containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose until completion of the study
exploring the utility of [18f]3f4ap for demyelination imaging

Conditions: Demyelinating Disorders; MCI; Alzheimer's Disease (AD); MS (Multiple Sclerosis); SCI - Spinal Cord Injury; Spinal Radiculopathy

Summary: the overall objective is to obtain an assessment of the pharmacokinetics of \[18f\]3f4ap in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (mci), alzheimer's disease (ad), multiple sclerosis (ms), spinal cord injury (sci) and spinal radiculopathy (sr).


Eligibility criteria:
inclusion: 1. male and female subjects must be ≥18 and \<90 years of age; 2. able to understand and provide informed consent prior to study procedures 3. must be in good health exclusion: 1. less than 18 years of age; 2. pregnant or breastfeeding; 3. any significant systemic illness or unstable medical condition; 4. pre-existing medical conditions or claustrophobic reactions; 5. research-related radiation exposure exceeds current pet center guidelines (i.e. 50 msv in the prior 12 months); 6. history of a bleeding disorder or are currently taking anticoagulants.

Keywords: 3f4ap demyelinating disorders ms sci ad
acute effects of artificial sweeteners or sugar on hemodynamic and metabolic stress responses

Conditions: Normal Subjects

Summary: this exploratory study aims at investigating the acute effects of artificially sweetened and sugar beverage consumption (as compared to water consumption) on acute hemodynamic and metabolic stress response.

this single-center study included five visits. the first two visits (screening and familiarization) allowed checking the eligibility of the volunteers. in case of inclusion, the subjects were assigned to a sequence of three experimental conditions (water, sugar and artificial sweeteners), in a randomized, crossover design. the experimental test was divided into 5 stages: 1. a 90 minutes baseline period (t=0-90 min), 2. a 30-min mental stress (ms; t=90-120 min), consisting in 5-min periods of stroop's color word conflict test alternated with 5-min periods of mental arithmetic test. 3. a 30-min ms recovery period (t=120-150), 4. a 3-min cold pressure test (cpt) was carried out, aiming at immersing one volunteer's forearm in an ice water container at 3°c, 3) a 15-min cpt recovery period (t=120-150). 60 min after the beginning of the metabolic test, volunteers will drink 25 ml every 15 min, after 10-sec mouth rinsing, of either an artificially- or sugar-sweetened beverages or water (control). hemodynamic stress responses will be measured by repeated blood pressure, heart rate and cardiac output. repeated venous blood samples will allow to assess metabolic stress responses. each condition (water, artificial sweeteners and sugar) will be preceded by a 2-day run-in period.

Eligibility criteria:
inclusion criteria: * healthy * caucasian * normal body mass index (18.5 ≤bmi≤ 25 kg/m2) * monophasic oral contraceptive exclusion criteria: * hypertension (blood pressure \>140/90 mmhg) * history or actual psychologic/cardiovascular troubles * anemia anamnesis * being pregnant * weight \< 50 kg * blood donation or participation to another study \< 8 weeks * claustrophobia * consumption of sugar/artifically-sweetened beverages drinks \> 5 dl/d * visual disturbances (daltonism) * low to moderate physical activity (\> 4h/wk) * smoker and narcotic consumption * caffeine (\> 400 mg/d) and/or alcohol (\> 10g/d) consumption * medical treatment * weight variation \> 3kg during the last month

Keywords: sweeteners sugar stress response
arginase inhibition in humans with obesity

Conditions: Obese; Endothelial Function

Summary: to evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity.

the study is performed on one group of subjects with body mass index \>35 and the absence of type 2 diabetes. inclusion criteria: body mass index \>35 kg/m2. exclusion criteria: age \>80 years. type 2 diabetes defined as \>7 mmol/l in fasting plasma glucose or \>11 mmol/l following 2h of oral glycemic load. myocardial infarction/unstable angina within 6 weeks prior to the study. treatment with oral anticoagulants (warfarin or new oral anticoagulants), raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm. any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol. participant in an ongoing study. unwillingness to participate following oral and written information. forearm blood flow is determined by venous occlusion plethysmography. endothelium-dependent vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and 210 ng/min). endothelium-independent vasodilatation is determined by infusion of sodium nitroprusside (snp; 1, 3 and 10 µg/min). each dose is given for 2 min at a rate of 2.5 ml/min. data are expressed as percentage change in forearm blood from baseline flow. fifteen subjects are included. on the day of the study the subject arrives to the laboratory after having a light breakfast. forearm vessels of the non-dominant arm are cannulated and forearm blood flow is determined as described above. baseline endothelium-dependent and endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin and snp, respectively. thereafter an intra-arterial infusion of the arginase inhibitor n-omega-hydroxy-nor-l-arginine (nor-noha) is administered as an intra-arterial infusion at a rate of 0.1 mg/min and is maintained for 120 min. the dose is based on a previous study by our group demonstrating improved endothelial function. endothelium-dependent and -independent vasodilatation is reassessed at 120 min of infusion.

Eligibility criteria:
inclusion criteria: bmi \>35kg/m2 exclusion criteria: age \>80 years. type 2 diabetes defined as \>7 mmol/l in fasting plasma glucose or \>11 mmol/l following 2h of oral glycemic load. myocardial infarction/unstable angina within 6 weeks prior to the study. treatment with oral anticoagulants (warfarin or new oral anticoagulants), raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm. any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol. participant in an ongoing study. unwillingness to participate following oral and written information.
protocol for genomically profiling, collecting, archiving and distributing blood and bone marrow specimens from children and young adults with hematologic malignancy

Conditions: Leukemia; Myelodysplastic Syndromes; Myeloproliferative Syndrome

Summary: this research study is a genomic profiling and repository study for children and young adults who have leukemia, myelodysplastic syndrome (mds) or myeloproliferative syndrome (mps). genes are the part of cells that contain the instructions which tell cells how to make the right proteins to grow and work. genes are composed of dna letters that spell out these instructions. genomic profiling helps investigators understand why the disease develops and the instructions that led to its development. understanding the genetic factors of the disease can also help investigator understand why the disease of some people can respond to certain therapies differently than others. the genomic profiling will be performed using bone marrow and blood samples that either have already been obtained during a previous clinical procedure or will be obtained at the time of a scheduled clinical procedure. studying the genetic information in the cells of these samples will provide information about the origin, progression, and treatment of leukemia and myeloproliferative syndromes and myelodysplastic syndrome. storing the bone marrow and blood samples will allow for additional research and genomic assessments to be performed in the future.

pediatric patients with new diagnosis or relapsed/refractory acute leukemia, mds/aml, chronic leukemia, myeloproliferative syndromes or myelodysplastic syndrome will be enrolled onto this study. at the time of enrollment, a sample of the leukemia will be submitted for genomic profiling using clia assay(s). this information will be returned to the treating oncologist. the study will collect follow up data on patient outcome and whether the genomic profiling influenced treatment. it is expected that about 100 people each year will take part in this research study at 8 medical centers in the united states

Eligibility criteria:
inclusion criteria: * age: birth to \< 30 years of age * diagnosis: -- patient with acute leukemia, chronic leukemia, mds/aml, myelodysplastic syndrome or myeloproliferative syndromes. disease can be newly diagnosed or relapsed/refractory. * pathology criteria: -- histologic confirmation of leukemia or myelodysplastic syndrome (mds) or myeloproliferative syndrome (mps) at the time of diagnosis or recurrence * specimen criteria: * sufficient sample available for genomic profiling or bone marrow aspirate/blood draw planned for clinical care which is anticipated to allow collection of minimum specimen for testing (see section 6.1 for description of specimen requirements) exclusion criteria: - insufficient leukemia or mds specimen available for profiling from diagnosis or recurrence (see section 6.1); or bone marrow evaluations not planned for clinical care; or peripheral blast percentage \<20%, or clinical blood draw not planned

Keywords: leukemia myelodysplastic syndromes myeloproliferative syndrome (mps)
nmes and pelvic fracture rehabilitation

Conditions: Trauma; Rehabilitation

Summary: objectives: the acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. patients have long periods of non-weight bearing causing muscle wastage. neuromuscular electrical stimulation (nmes) has proven to minimise muscle loss. however, this has not previously been investigated within this patient population. design: double blind, randomised, feasibility study. setting: nhs trust hospital setting. participants: nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture. interventions: the intervention group completed six weeks of nmes. the placebo group used transcutaneous electrical nerve stimulation (tens). main outcome measures: peak torque (nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. compliance and intensity levels were recorded. feasibility of nmes was evaluated using a feasibility questionnaire. pain was measured at six and 12 weeks using a visual analogue scale (vas).


Eligibility criteria:
inclusion criteria: * inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent. * pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (orif) were considered. exclusion criteria: * exclusion criteria were patients who could not comply with the nmes or who had previous mental health diagnosis. * patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.
study of the concentration-effect relationship of nivolumab in patients with kidney or lung cancer

Conditions: Kidney Cancer; Lung Cancer

Summary: to assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration. collection of standard data prospectively.

nivolumab is a monoclonal antibody used for the treatment of non small cell lung carcinoma and renal cell carcinoma. huge variability exists between patients treated by nivolumab in terms of efficacy and side effects. like others monoclonal antibodies, a relation between concentration and effects of nivolumab may exist. the aim of this study is to assess the relationship between blood concentration of nivolumab and progression free survival, overall survival and side effects on the one hand, and on the other to describe pharmacokinetic of nivolumab

Eligibility criteria:
inclusion criteria: * patient with squamous or non squamous non small cell lung cancer stage iv or patient with renal cell carcinoma stage iv * patient receiving nivolumab or who will receive nivolumab * age ⩾ 18 years old * oms stage ≤ 2 * evaluable disease exclusion criteria: * active brain metastasis not treated before by surgery or radiotherapy * autoimmune disease * patient having objected to the processing of his data

Keywords: nivolumab monoclonal antibody opdivo antineoplastic agent elisa pharmacokinetic
osteogenesis imperfecta and balance

Conditions: Osteogenesis Imperfecta

Summary: osteogenesis imperfecta (oi), also known as brittle bone disease, is a group of genetic disorders that mainly affect the bones. it results in bones that break easily. its severity may be mild to severe. other symptoms may include a blue tinge to the whites of the eye, short height, loose joints, hearing loss, breathing problems and problems with the teeth. physiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while minimizing the risk of fracture, and the use of support cushions to improve posture.

this study aimed to assess the efficacy of whole body vibration on balance and motor function in children with osteogenesis imperfecta. whole body vibration (wbv) therapy is targeted at musculoskeletal strengthening and has been trialed in a variety of conditions. wbv has been shown to have therapeutic advantage in various osteopenic preclinical models and populations such as postmenopausal women (improved mobility, muscle strength, postural strength, and bone density) and children with osteogenesis imperfecta (improved mobility)

Eligibility criteria:
inclusion criteria: 1. their age was ranging from six to twelve years 2. children participated in this study were from both sexes 3. all children with stable medical and psychological status. 4. they were able to follow the verbal commands or instructions during testing. exclusion criteria: 1. children with visual or auditory problems. 2. children with any cognitive problems. 3. children without deformity

Keywords: osteogenesis imperfecta whole body vibration balance motor control
evaluating mental health improvements after using home phototherapy device with uvb leds

Conditions: Usability; Quality of Life

Summary: the primary objective of this study is to evaluate the satisfaction of users with the mysolius device by a non-professional in a home use environment. the secondary objective of this study is to demonstrate the safety and effectiveness of the mysolius device in the improvement of mood/quality of life score.

after being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. participants who meet the eligibility requirements will be sent a study device to use in their home environment. prior to beginning treatment with the device, participants will fill out a quality of life questionnaire. participants will use the device twice per week, once for treatment on the front side and once for treatment on the back side of the body. participants will use the device twice a week for 16 weeks, for a total of 32 treatments. after the 16 week treatment duration, participants will fill out a final quality of life questionnaire and a device usability questionnaire.

Eligibility criteria:
inclusion criteria: * men and women, age 18 years or older with fitzpatrick skin types 1,2,3,4,5 and 6. * the patient can understand the information provided to them and who have given written informed consent to the study. * the patient can understand and complete self-administered questionnaires. * the patient is able and willing to follow study procedures. * women of child-bearing potential must confirm use of an effective contraceptive for 30 days prior to enrolling and continued use throughout the study or have a negative pregnancy test. exclusion criteria: * history of underlying photosensitivity. * subjects who are pregnant * patients that have granulomatous disorders (such as sarcoidosis). * use of medications that cause a photosensitivity reaction. * history of skin cancer in the last 5 years. * patients with history of hypocalcemia (calcium \ 10.6mg%). * taking drugs known to influence vitamin d metabolism, such as glucocorticoids,antiseizure medications, or hiv/aids medications. * patients with a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease within 3 months. * intentional artificial uv exposure (e.g. tanning bed, uvb phototherapy use) in the last 60 days or planned use while participating in the study. * participation in an investigational drug study within 30 days of the screening. * any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
12-month stability of diurnal iop control on cosopt

Conditions: Glaucoma

Summary: to determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with cosopt

glaucoma is a potentially-blinding but treatable eye disease. a major risk factor for glaucoma is elevated intraocular pressure (iop). iop is a dynamic variable (like blood pressure)-it changes over time. the more it changes, the more likely patients are to get worse. glaucoma is treated by lowering iop. cosopt is a medication that lowers iop. little is known about how well cosopt reduces iop fluctuations. in this study, we plan to measure the iop in both eyes of 10 glaucoma patients treated with cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. untreated baseline iop will be measured on a similar long day before beginning treatment with cosopt. this methodology will allow us to compare iop fluctuations with and without cosopt, and also to learn about long-term control of iop fluctuations in eyes treated with cosopt.

Eligibility criteria:
inclusion criteria: * bilateral open-angle glaucoma exclusion criteria: * contraindications to cosopt * pathology affecting tonometry

Keywords: glaucoma diurnal intraocular pressure
effect of repetitive transcranial magnetic stimulation on neurological recovery in patients with ischaemic stroke

Conditions: Stroke Ischemic

Summary: the goal of this clinical trial is to learn if transcranial magnetic stimulation(rtms) can improve neurological rehabilitation in patients with acute ischemic stroke. the main questions it aims to answer are: can rtms promote recovery of limb impairment in patients with acute ischemia? can rtms cause changes in the functional connections of brain networks in patients? researchers will compare rtms therapy to non-stimulation therapy to see if rtms is effective in promoting neurological recovery from ischemic stroke. participants will: receive rtms or sham stimulation with lf-rtms on the contralateral m1 of the brain lesion for 20 minutes, 1200 pulses, 120% rmt, and a treatment period of 5 days； be evaluated on a scale before and after treatment


Eligibility criteria:
inclusion criteria: 1. the age range is 18\~75 years old 2. meet the diagnostic criteria of china acute ischaemic stroke diagnosis and treatment guidelines 2018 and confirmed by head ct or mri scanning 3. acute stage of the disease \&lt;14 days and stable condition 4. stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions) 5. patients with upper limb muscle strength ≥ grade 3, able to perform fnirs tasks with the patient. 6. subjects were right-handed 7. participants give their informed consent and sign an informed consent form exclusion criteria: 1. those who have metal implants or any electronic devices in their body 2. those with previous epilepsy or mental abnormality. 3. combined with serious heart, liver, lung and other important organ failure 4. those who have brain haemorrhage or bleeding tendency. 5. deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage. 6. patients with history of craniocerebral trauma and craniocerebral surgery. 7. those with severe cognitive and communication disorders who are unable to cooperate -

Keywords: rtms stroke ischemic
assessment and rehabilitation of cognitive impairments in pediatric survivors of cancer

Conditions: Neoplasms

Summary: this research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.

the purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.

Eligibility criteria:
inclusion everyone: * at least 9 years of age and less than 17 years patients * diagnosis of brain tumor or acute lymphocytic leukemia (all) * completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery control group * typical for age exclusion everyone: * non-english speaking (translated cognitive testing and mri assessments unavailable) * mri contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker * major sensory deficit disorders, including but not limited to blindness or deafness patients * shunt placement * received bone marrow transplant * history of neurologic, psychiatric, developmental or major medical condition (eg, diabetes) not related to cancer * participation in any concurrent cognitive rehabilitation study control group * history of neurologic, psychiatric, developmental or major medical condition (eg, diabetes)

Keywords: carcinomas squamous cel adenocarcinoma acute lymphocytic leukemia